THE United States on Wednesday authorized Pfizer Inc’s antiviral COVID-19 pill for people ages 12 and older at risk of severe illness, the first oral and at-home treatment as well as a new tool against the fast-spreading Omicron variant.
Pfizer’s antiviral regimen, Paxlovid, was nearly 90% effective in preventing hospitalizations and deaths in patients at high risk of severe illness, according to data from the company’s clinical trial. Recent lab data suggests the drug retains its effectiveness against Omicron, Pfizer said.
Pfizer raised its 2022 production projections to 120 million courses of treatment from 80 million and said it was ready to start immediate delivery in the United States. The treatment’s two-drug regimen includes a new medicine and a second older antiviral called ritonavir.
The FDA said it authorized Paxlovid for emergency use for the treatment of mild-to-moderate disease in adults and children 12 years and older who are at high risk for progression to severe COVID-19.
The drug is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset, the FDA said. The pills are meant to be taken every 12 hours for five days.
While the clinical trials did not include patients under the age of 18, Pfizer said, the authorized adult dosing regimen is expected to result in comparable blood concentration levels of the drug in pediatric patients 12 and older weighing at least 40 kg (88.2 lbs).
The second drug, ritonavir, is known to have interactions with some other prescription medicines. Pfizer has said that should be manageable and suggested most patients would be able to lower the dose of their other medications while being treated for COVID-19.
Pfizer said it plans to file a new drug application with the FDA in 2022 seeking full regulatory approval.
